RecruitingACTRN12616000150448

The Persistent Pelvic Pain (PPP) Study: Factors influencing the outcomes in women presenting with persistent pelvic pain

The Persistent Pelvic Pain Study (PPP): Factors influencing the outcomes in women presenting with persistent pelvic pain


Sponsor

Prof Sonia Grover

Enrollment

250 participants

Start Date

Feb 9, 2015

Study Type

Observational

Conditions

Summary

AIMS: This study aims to clarify factors impacting upon outcomes in women presenting with persistent pelvic pain (PPP). The study team are keen to understand whether there are specific features of the woman, including the type and severity of the pain, the duration of these symptoms, or her response to her pain, that might influence or predict her outcome and thus potentially allow selection of the most appropriate therapeutic approach for specific patient characteristics. METHODS: Pelvic pain is the most common indication for referral to the outpatient gynaecology clinic. Information regarding this study, including study information, consent, and questionnaires regarding symptoms, quality of life(QoL), pain catastrophisation scale(PCS), will be sent to patients at the same time as their appointment information. On arrival at their first appointment, the research assistant will approach the prospective participants to ensure that initial paperwork and questionnaires were received, and offer the opportunity for questions. If the patient agrees to participate and has not completed the questionnaires they will be encouraged to do so whilst waiting. Consent to access patient data from medical records will also be sought. All clinical decisions regarding management will be independent of study questionnaires. Clinicians, who with the patient, decide that surgery for the PPP is warranted, will be asked to complete a brief survey regarding the factors influencing this decision. Follow-up questionnaires at 6 monthly intervals will be sent (either electronic, utilising survey monkey, or in paper format with reply paid envelopes, depending on patient preference). The pilot study will conclude at a minimum of 36 months. Patient questionnaires will take 15-30minutes.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study follows women who attend a gynaecology clinic for persistent pelvic pain to better understand what affects their recovery. Researchers are trying to identify which patients respond best to which treatments — whether physical, surgical, or psychological. Questionnaires about pain, quality of life, and emotional wellbeing will be collected at the start and every six months for at least three years. You may be eligible if: - You are a woman between 18 and 50 years old - You have been referred to a gynaecology clinic for pelvic pain, painful periods, painful sex, or lower abdominal pain You may NOT be eligible if: - You are actively trying to become pregnant or being investigated for infertility - You have a large ovarian cyst or endometrioma (greater than 4 cm) - You have previously had a hysterectomy Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

On presentation, participants will complete a questionnaire including 1) The Pain Catastrophizing Scale (PCS), 2) The World Health Organisation Quality of life - Bref Questionnaire, and 3) their pelvi

On presentation, participants will complete a questionnaire including 1) The Pain Catastrophizing Scale (PCS), 2) The World Health Organisation Quality of life - Bref Questionnaire, and 3) their pelvic pain levels in the last 3 months. All clinical decisions regarding management will be independent of study questionnaires. Follow-up questionnaires at 6 monthly intervals will be sent. We will recruit for 18months, and the study will conclude follow-up at a minimum of 36 months for each patient. The follow-up period is based on an attrition rate of 30% (gauged from original pilot data). Data will be analysed at each 12-month point - if clinically significant outcomes are determined, the option of gaining ethics for an extension of the follow-up period will be explored.


Locations(1)

Mercy Hospital for Women - Heidelberg

VIC, Australia

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ACTRN12616000150448